(306 days)
No
The device description focuses on the physical characteristics and materials of the screws, and there is no mention of AI or ML in the provided text.
Yes
The device is described as providing a fixed anchorage point for orthodontic appliances to facilitate the movement of teeth, which is a therapeutic purpose.
No
The provided text describes the PSM LOMAS / BENEFIT Screws as temporary anchorage devices (TADs) used in orthodontics to facilitate tooth movement. Their function is mechanical (providing anchorage), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states that the device is made of Titanium alloy and describes physical components like heads, platforms, bodies, and necks. It also mentions performance studies involving breakage and fatigue tests, which are relevant to physical hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing a fixed anchorage point for orthodontic appliances to facilitate tooth movement. This is a mechanical function within the body.
- Device Description: The description details a physical screw made of titanium alloy designed for insertion into bone. This is a medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
Product codes
OAT
Device Description
The PSM LOMAS / BENEFIT Screws are made of Titanium alloy. The bone screws are designed to be used transmucosally for osseous orthodontic anchorage. They are used as Temporary Anchorage Devices (TAD) for orthodontic treatments. The LOMAS screws (Ø1.5 mm and 2.0 mm), as well as the BENEFIT screws (Ø2.0mm and 2.3mm) come in two diameters and all screws come in five lengths (7 mm, 9 mm, 11 mm, 13 mm, and 15 mm). The screws are divided in five groups of screws, LOMAS Standard, LOMAS Quattro, LOMAS Quattro V and BENEFIT Screws. The range of providing flexibility for specific orthodontic applications.
The screws consist of either three or four components: head, platform, body (thread) or moreover neck.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adolescents greater than 12 years of age and adults.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
On the PSM LOMAS / BENEFIT Screws were performed Breakage and Fatigue Tests, Material Tests, Validation Tests of sterile barrier system and packaging system, Sterilization Validation Tests. Microbiological Test for determination of microorganisms, and several Clinical Justifications and Studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042345, K050257, K090476, K023067, K042289
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
510(k) Summary
,'
510(k) Summary as required by section 807.92(c)
Submission Applicant:
psm Medical Solutions Moltkestrasse 41 78532 Tuttlingen / Germany : Phone: +49 7461 96637-0 Fax: +49 7461 96637-29 E-mail: info@@psm.ms
Establishment Registration Number:
3008323540
Application correspondent/Contact person: think!
Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen / Germany
Phone: +49-7462-924 051 Fax: +49-7462-924 128 E-mail: andrea@thinkworks.biz
Trade name: PSM LOMAS / BENEFIT Screws
Common name:
.
. .
Root-form endosseous dental implants, Orthodontic endosseous dental implant
Classfication name:Endosseous dental implant, Dental -21 CFR 872.3640
Product Code: OAT
Predicate Devices:
-
Lin/Liou Orthodontic Mini Anchor System (LOMAS) K042345 and Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) K050257 - manufactured by: Mondeal Medical Systems GmbH.
-
Syntec Orthodontic Mini Screws K090476 manufactured by Syntec Scientific Corporation
-
IMTEC Sendax MDI ORTHO K023067 made by IMTEC Corporation
-
MDI ORTHO K042289 made by IMTEC Corporation
KING 392
1
Image /page/1/Picture/1 description: The image shows a logo for "psm MEDICAL SOLUTIONS". The letters "psm" are in a stylized font, with the "p" in lowercase and the "s" and "m" in uppercase. The words "MEDICAL SOLUTIONS" are in smaller, uppercase letters below the "psm".
Description of the Device:
The PSM LOMAS / BENEFIT Screws are made of Titanium alloy. The bone screws are designed to be used transmucosally for osseous orthodontic anchorage. They are used as Temporary Anchorage Devices (TAD) for orthodontic treatments. The LOMAS screws (Ø1.5 mm and 2.0 mm), as well as the BENEFIT screws (Ø2.0mm and 2.3mm) come in two diameters and all screws come in five lengths (7 mm, 9 mm, 11 mm, 13 mm, and 15 mm). The screws are divided in five groups of screws, LOMAS Standard, LOMAS Quattro, LOMAS Quattro V and BENEFIT Screws. The range of providing flexibility for specific orthodontic applications.
The screws consist of either three or four components: head, platform, body (thread) or moreover neck.
Indications for Use:
The PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
Technological characteristics compared to the Predicate Devices:
The PSM LOMAS / BENEFIT Screws are similiar to the Predicate Devices Lin/Liou Orthodontic Mini Anchor System (LOMAS), Syntec Orthodontic Mini Screws, and IMTEC MDI ORTHO in terms of technical characteristics, Indications for Use, material, target population, performance, safety, effectiveness and biocompatibility characteristics. Moreover the design and sizes of the new device are strongly identical with the predicates. Therefore the PSM product can be deemed substantially equivalent for its indicated use.
Performance data:
On the PSM LOMAS / BENEFIT Screws were performed Breakage and Fatigue Tests, Material Tests, Validation Tests of sterile barrier system and packaging system, Sterilization Validation Tests. Microbiological Test for determination of microorganisms, and several Clinical Justifications and Studies.
Summary
, " .
The information submitted demonstrates the PSM LOMAS/BENEFIT Screws are substantially equivalent to predicate orthodontic anchorage screws.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
PSM MEDICAL SOLUTIONS C/O Ms. Andrea Pecsi THINK! SCHWARZWALDSTRASSE 5 TUTTINGEN BW GERMANY 78532
DEC 1 4. 2011
Re: K110392
Trade/Device Name: PSM LOMAS / BENEFIT Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: December 5, 2011 Received: December 8, 2011
Dear Ms. Pecsi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Pecsi
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony V. Mann
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use Statement
510(k) Number (if known): K110392
Device Name: PSM LOMAS / BENEFIT Screws
. '
Indications for Use:
:
The PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
X Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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ﺎ ﺗﺄﺗﻴﻨﺎ ﻓﻲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ··
:
Suen Ruoor
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K160392